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临床试验/NCT03693716
NCT03693716已完成不适用

Arthroscopic Dynamic Anterior Capsular Stabilization With Trans Subscapular Long Head of the Biceps Tenodesis in Anterior Shoulder Instability - Clinical and Imagiological Results

Hospital de Egas Moniz2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2018年9月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
18
试验地点
2
主要终点
Shoulder range of motion (ROM)

研究概览

简要总结

Clinical study of patients with a history of traumatic anterior shoulder dislocations to test the hypothesis that the arthroscopic dynamic anterior capsular stabilization technique with trans subscapular long head of the biceps tenodesis produces progressive good clinical and imagiological results.

详细描述

Patients with a history of traumatic anterior shoulder dislocations with documented imagological Bankart and HillSachs lesions who meet the eligibility criteria will be enrolled in the study and undergo an arthroscopic dynamic anterior capsular stabilization technique with trans subscapular long head of the biceps tenodesis. All patients will be clinically and radiologically/imagiologically assessed preoperatively and at the 6-months, 12-months and 2-years postoperative evaluations. The range of motion (ROM), shoulder abduction strength, Constant, ROWE and WOSI scores will be compared from preoperative to 6 months postoperative; from 6 months postoperative to 12 months postoperative; and from 12 months to 2 years postoperative (paired-samples t-test, two-tailed). All continuous variables will be compared between the group of patients with failures (a failure is defined as a patient who suffers an objective re-dislocation episode during the 2-year follow-up) and the group without failures (Mann-Whitney U test). All categorical variables and outcome results will be compared between the two groups (Fisher's exact test). A significant difference will be defined as P<0.05.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Bankart lesion and Hill Sachs lesions on the magnetic resonance imaging
  • one or more traumatic anterior shoulder dislocation episodes
  • contact or forced overhead sport or work activity

排除标准

  • proximal humerus fracture
  • rotator cuff tear requiring repair

结局指标

主要结局

Shoulder range of motion (ROM)

时间窗: 2 years

Bilateral shoulder active range of motion (ROM): elevation (0 -180º), abduction (0 -180º) and external rotation (0 -100º), measured in degrees ; and internal rotation, defined as the highest vertebral body that the patient's thumb can reach, converted afterwards to a scale of 1-5 points: lateral thigh=0; buttock=1; sacrum=2; lumbar=3; 12th thoracic vertebra=4; 7th thoracic vertebra=5; for every scale range provided, higher values represent a better outcome.

次要结局

  • Shoulder Strength(2 years)
  • The Western Ontario Shoulder Instability Index (WOSI)(2 years)
  • The ROWE score(2 years)

研究者

发起方
Hospital de Egas Moniz
申办方类型
Other
责任方
Principal Investigator
主要研究者

Clara Isabel de Campos Azevedo

Shoulder Surgery Unit Coordinator

Hospital de Egas Moniz

研究点 (2)

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